Dominic Chiarelli, JD

by Dominic Chiarelli

Research 2.0: Embracing Social Media in Clinical Trials

Social media has a place in clinical trials

Social media is a powerful and widespread tool that has helped to topple governments, drive social change, and place Stephen Colbert’s name on space modules, bridges, and mascots. It also brings an entire new dimension to clinical trials by offering a widely available medium in which the public, participants, and health care professionals can extend their reach, exchange information, and build lasting highly-engaged communities. Despite this vast potential, the research community has been rather slow to adopt social media. This hesitancy is likely due to a lack of clear federal guidance regarding the appropriate considerations for the use of social media in research and, somewhat ironically, the ability of social media to reach and impact the public. In this void, IRBs (like Quorum Review) have been working with Sponsors to develop social media plans that are consistent with the principles of the federal regulations, while also maintaining the utility of the medium. Here’s what we’ve learned:

  • Social media is all about interactions

Social media refers to an interactive platform for electronic communications, used by groups of people to create, share, and exchange information.[1] The term is extremely broad in practice and includes clinical trial websites, social networking websites (Facebook & Twitter), social photo/video sharing websites (YouTube & Instagram), online advertisement campaigns, blogs, mobile apps, and more. What truly defines social media is the ability to interact with participants and others on a continuing basis. This ability allows the medium to function as an effective tool in recruiting and retaining participants as well as in collecting and providing information. This also leads to one of the most important considerations for any social media plan: identifying which interactions are sufficiently specific to a research activity that prior IRB review and approval must be obtained.

  • Social media pushes the boundaries of the established research regulations and guidance

The federal regulations governing human subjects research were promulgated before the internet assumed its prevalence in everyday life and without consideration for possible innovations like social media.[2] Consequently, when reviewing social media, IRBs are left to work with only broad principles like their authority to review and approve all research activities, the need to ensure that the research takes adequate provisions to protect privacy and confidentiality, and the need to ensure that informed consent is appropriately sought and obtained.[3] Federal guidance has stepped in and provided some additional specificity including that web-based activities should be subject to the same requirements as print media and that study related communications should remain consistent with the principles of informed consent regardless of the medium and any inherent limitations it may have.[4] Federal guidance has also clarified that IRB reviewable subject matter can be limited to communications directly related to a specific clinical trial and that in certain cases IRB review can be considered unnecessary when such review would provide participants no additional safeguards.[5]

  • Social media may benefit from draft FDA guidance indicating new possible flexibilities

In 2014, the FDA issued three related pieces of draft guidance concerning the use of internet/social media platforms with regards to prescription drugs and medical devices.[6] Although the regulatory basis for each guidance is the FDA’s authority over labeling, they likely represent a good guidepost for how the FDA would view similar activities in the research context.[7] For example, the FDA is unequivocal, and consistent with past research guidance, in stating that sponsors cannot use any limitations of a chosen social media forum (character limitations, in particular) to excuse publishing information that may appear misleading or that overemphasizes the possible benefits from participation.[8] The FDA also clarified that sponsors retain responsibility for any communication under their direct control or influence[9] and that if choosing to respond to inaccurate or misleading information from an independent third party (i.e., user generated content) that the response must be tailored, accurate, and clearly attributable to the sponsor.[10] The FDA also recognized that requiring prior review of interactive communications potentially compromises their effect and declared an intention to be flexible if sponsors are able to provide an adequate description of their initial and continuing social media activities.[11] An adequate description includes clear identification of all anticipated social media activities and annotated screenshots demonstrating the look and feel for all social media interactions. These initial efforts by the FDA are encouraging and appear to be helping to thaw the ice around the use of social media in the context of FDA regulated products.

Quorum’s approach to social media

Quorum has embraced social media. Our approach centers on identifying which activities are reviewable subject matter and then applying the letter and the spirit of the regulations and current guidance as it fits the circumstances.[12] Quorum does not consider activities that are only tangential to a specific clinical trial, and are really intended for community building, as reviewable subject matter. A good example of this would be stories in public papers or academic journals regarding the value of research or the challenges of living with a particular disease. Other examples would be celebrity tweets about living with a particular condition or YouTube channels dedicated to a particular research institution.

Quorum also expects that for each social media use a hard copy final mock-up or storyboard, including all images, will be submitted for review and approval. This would include all study-specific home pages, posts, tags, and ads. What Quorum is looking for is instances in which the communication could be viewed as potentially misleading (treatment misconception) or even harmful to the rights and welfare of participants (un-blind the study). Thankfully, social media content can usually be reviewed using expedited review, so new posts or changes to approved posts can be quick to turnaround and implement.

Quorum also generally expects a comprehensive social media management plan. This plan ideally provides rationale for the chosen social media, identifies the type of information that will be shared and/or sought, defines both the reviewable and non-reviewable content that is expected to be posted, addresses any potential special privacy or confidentiality concerns with the chosen social media, and describes whether user generated content will be active and how/whether the host will monitor such content. In reviewing the management plan, Quorum will look for and require additional safeguards whenever necessary. Such additional safeguards could include a clear and concise statement regarding the intended use of the social media (not to be taken as medical advice), limits on what can be collected, additional controls for user generated content (review prior to publishing), or an escalation process when a user reports an adverse event or information that may compromise the study.

Without additional federal guidance specific to research, IRBs and sponsors are left to work together to figure out how best to utilize social media while respecting the rights and welfare of participants. Quorum feels uniquely qualified to help lead in this regard due to our prior social media experiences, our vast exposure in terms of the quantity and the types of clinical research we review, and our depth of regulatory expertise. We look forward to working with sponsors to better understand the capabilities of social media while also hopefully improving and enriching the research experience for participants.

[1] IRB Review of the Use of Social Media in Research, C. Gearhart, The Monitor (2012).

[2] Considerations and Recommendations Concerning Internet Research and Human Subjects Research Regulations, SACHRP (2013).

[3] 21 CFR 56.109(a)/45 CFR 46.109(a) & 21 CFR 56.111(7)/45 CFR 46.111(7)

[4] Guidance on Institutional Review Board Review of Clinical Trial Websites, OHRP (2005).

[5] Recruiting Study Subjects – Information Sheet, FDA (1998).

[6] For Industry: Using Social Media.

[7] 21 U.S.C. 352(a) and 21 U.S.C. 352 (n),(q), and (r).

[8] Internet/Social Media Platforms with Character Space Limitations-Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices, FDA (2014).

[9] Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media for Prescription Human and Animal Drugs and Products, FDA (2014).

[10] Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices, FDA (2014).

[11] Id at 9.

[12] Id at 4 and 5.

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